ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001— 510(k) K864500

Substantially Equivalent

Analytic Technology

FDA 510(k) clearance K864500 for ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001, Substantially Equivalent on 1987-03-19. Applicant: Analytic Technology.

Clearance details

Applicant
Analytic Technology
Product code
Code LQY
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redmond, WA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LQY

product code LQY
Malfunction
504
Total
504

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.